Boise-area wellness centers use oxygen devices authorities deem unsafe. What we found
Wellness centers offering to boost oxygen in your blood and tissues say the therapy can help cure a plethora of ailments. But fire officials in some states and some medical organizations say the devices used in the therapy at best are not worth your money and at worst can be deadly.
Treasure Valley fire marshals and the State Fire Marshal’s Office met July 26 to discuss complaints about hyperbaric chambers, which are pressurized chambers that allow people to breathe higher levels of oxygen to supply more oxygen to tissues and organs.
The controversy revolves around the use of low-pressure, or soft-shell, chambers, which aren’t capable of reaching the higher pressures their hard-shell counterparts are able to.
Authorities elsewhere say some chambers of the types used by wellness centers in Boise, Meridian and Eagle do not meet fire-safety or pressure-vessel safety standards and do not have clearance from the U.S. Food and Drug Administration.
Low-pressure chambers, many of which are illegally imported, are at risk of explosions and fire due to the high concentration of oxygen. A power disruption could also cause the chambers to deflate, suffocating the person inside.
These types of inflatable chambers, which are portable and seal with a zipper, were originally designed for divers and mountain climbers to use until they could be taken to a hard-shell chamber for treatment, according to the National Hyperbaric Treatment Center.
The State Fire Marshal’s Office declined to respond to requests from the Idaho Statesman asking what, if anything, it is doing about the chambers. A spokesperson said the office is working on a public statement.
High-pressure chambers are typically used by physicians in hospitals and other medical clinics to treat conditions such as decompression sickness, carbon monoxide poisoning and diabetic foot ulcers. Accredited facilities such as the Saint Alphonsus Wound Healing & Hyperbaric Medicine program in Boise provide these services. These chambers are not at issue.
Low-pressure or mild hyperbaric chambers, on the other hand, are not FDA-approved for use in hyperbaric oxygen therapy, except for treating climbers and divers with altitude sickness. Wellness centers claiming to use them for other ailments are providing “off-label” treatments.
Earlier this year, fire marshals in North Carolina halted the operation of several mild hyperbaric chambers after concluding that the chambers used by a rapidly expanding company, Restore Hyper Wellness, and other wellness centers did not comply with safety standards, according to reporting by The News & Observer.
Restore Hyper Wellness has two locations in Idaho, one in Boise and one in Meridian. A complaint to local fire authorities named these locations among other wellness centers in the Treasure Valley.
“Restore is the leading provider of mild hyperbaric oxygen therapy across the country and, in seven years, has delivered over 140,000 mild hyperbaric oxygen therapy sessions to over 11,000 clients across more than 150 locations without a single fire incident,” a corporate spokesperson for Restore Hyper Wellness said in an email to the Statesman.
In June, the American Medical Association adopted a policy to “oppose the operation of ‘mild hyperbaric facilities’” until there is adherence to safety protocols, proper medical supervision, and scientific support for the treatment. The association decided to work with regulatory bodies like the FDA to close hyperbaric therapy operations that do not meet these standards.
What are the safety concerns?
In 2009, a hyperbaric chamber in Florida caught fire and killed a 4-year-old and his grandmother. And in 2011, a 19-year-old autistic man in North Carolina suffocated after falling asleep inside a mild hyperbaric chamber used at home. The chamber was shipped to his home from a nearby clinic for temporary use.
Fire marshals have also halted the operation of some mild hyperbaric chambers in Utah, Georgia and South Carolina, said Tom Workman, recently retired director of quality assurance and regulatory affairs for the Undersea and Hyperbaric Medical Society, a nonprofit, nonregulatory organization that supports hyperbaric medical research.
The Undersea and Hyperbaric Medical Society says mild hyperbaric treatments available in wellness centers and health spas are generally not supervised or prescribed by physicians, have unproven efficacy, and often fail to adhere to safety standards, putting individuals at risk for injury and death. The society has several position statements on hyperbaric oxygen administration.
Some wellness centers are pairing low pressure hyperbaric chambers with oxygen tanks and oxygen concentrators — a combination explicitly not cleared by the FDA.
In a warning to consumers, the FDA says “homemade” hyperbaric oxygen therapy poses fire and suffocation risks. The FDA also warned of the risk of explosions and fires at unaccredited facilities, because high concentrations of oxygen present a fire hazard.
In Canada, authorities have taken steps to seize unlicensed hyperbaric chambers. And in Ireland, the government decided to regulate all hyperbaric facilities to make sure the devices are being used as the manufacturers intended. The new regulations stop mild hyperbaric centers from carrying out treatments.
Some wellness centers allow people to bring their cellphones into chambers, said John Peters, executive director of the Undersea and Hyperbaric Medical Society. Electronic devices can provide a deadly spark, and the elevated oxygen level can help the fire burn.
“We have to also remember that the human body makes a great fuel,” Peters said.
Corinne Kohake, manager of Restore Hyper Wellness in Boise, told the Statesman that the company is positive that the way it carries out mild hyperbaric oxygen therapy is safe.
The company has consulted with independent experts, conducted internal research and had tests conducted by MET Laboratories on the company’s mild hyperbaric oxygen therapy, Kohake said. MET Laboratories conducts safety testing and certification for electrical products.
“The safety of our clients, employees and environment is our paramount priority,” Kohake said. “We have an impeccable safety record with our mild hyperbaric oxygen therapy service, and we will continue to undertake every effort to ensure that remains true at all times going forward.”
Are wellness centers providing medical services? The distinction matters
In a public comment on fire safety standards, Martin Gresho, a fire protection engineer consultant for Restore Hyper Wellness, said low-pressure oxygen therapy has minimal fire risk, yet the company’s facilities are subjected to safety codes designed for high-oxygen, high-pressure environments.
Restore Hyper Wellness’ comment also said that its services are therapeutic, not medical, meaning that the code should not apply. Exemption from health care-specific standards is part of the company’s appeal in North Carolina, The News & Observer reported.
Restore Hyper Wellness employs licensed health care professionals. Customers undergoing mild hyperbaric oxygen therapy complete a medical waiver and have a TeleMed call with a medical professional, the company’s website says.
Tim Jolicoeur, owner of Boise’s Restore Hyper Wellness franchise, told the Statesman by phone that the therapy is one of the center’s medical procedures.
“We actually have the best medical services, whether it’s IVs or what have you,” Jolicoeur said. “Everything that we’re doing, we have cleared through our medical department with the MDs.”
He added that most of the store’s approvals are completed at a corporate level, not at a local level.
At the company’s location in Boise, a registered nurse watches over the patients and checks their vitals, according to Kohake. Physicians are available via phone or Zoom call at all times, she says.
“We have an RN on staff to be able to oversee it,” Kohake told the Statesman. “They get checks on certain parameters continuously while undergoing pressure.”
Is mild hyperbaric therapy effective? Pressure makes the difference
Standard forms of the therapy can be effective for certain ailments.
Mild forms, however, have so little evidence of any benefit that Derall Garrett, director of the Hyperbaric Facility Accreditation program at the Undersea and Hyperbaric Medical Society, says they aren’t worth the money. Garrett is a former hyperbaric chamber technician.
“There’s a big swing between the two,” Garrett told the Statesman by phone. “Definitely from a mild standpoint, you’d have to spend a considerable amount of time in there to get any benefit.”
He said typical, medically approved, hyperbaric treatment involves 2 ATA for 90 minutes at 100% oxygen. An ATA, or one atmosphere absolute, is the average atmospheric pressure exerted at sea level, or 14.7 pounds per square inch, according to the Hyperbaric Centers of Texas Inc. Two ATA is twice the atmospheric pressure exerted at sea level.
Mild hyperbaric oxygen therapy involves using three quarters less pressure and less than half the amount of oxygen employed in a regulated, hard-shell chamber, Garrett said.
“That’s a typical treatment,” he said. “With a mild hyperbaric chamber, the max pressure is typically no more than 4 PSI. Basically, it’s considerably less pressure, and then you’re giving them a concentration of oxygen, which, at best, is probably 50%.”
Soft-shell chambers cost about $5,000, according to Garrett. Hard-shell chambers run around $140,000, making them a less desirable option for wellness centers to buy.
The biggest difference between medical therapy and mild therapy is the pressure, according to Dr. Jason Quinn, an emergency medicine physician at the Saint Alphonsus Health System.
Mild hyperbaric units don’t approach the kind of pressures needed for true therapy, Quinn said. If a chamber doesn’t provide true hyperbaric pressures, he said, it won’t provide any more benefit than simply breathing oxygen while sitting in your chair.
The Saint Alphonsus Wound Healing & Hyperbaric Medicine program in Boise is one of four hospital-affiliated wound care and hyperbaric centers accredited by the Undersea and Hyperbaric Medical Society in Idaho, Workman said. The other three accredited centers are at St. Luke’s Health System in Meridian, Portneuf Medical Center in Pocatello and Saint Alphonsus Medical Center in Nampa.
The FDA advises people to receive treatment at a center that has been inspected and accredited by the organization.
Undersea and Hyperbaric Medical Society accreditation means a center has “met the highest standards of care and patient safety” through a rigorous evaluation of the adequacy of “facility, equipment, staff and training to ensure that the utmost quality is maintained,” the society says.
What can mild hyperbaric therapy treat?
The large, zippered bags commonly used for mild hyperbaric therapy are cleared by the FDA only for altitude sickness. But wellness centers often tout mild hyperbaric therapy as treatment for a wide range of ailments, according to the FDA.
“If you are considering the use of a (hyperbaric oxygen therapy) device for yourself or a loved one, be aware that some claims of what it can do are unproven,” the FDA says.
The FDA notes on its website that the devices are not proven to cure cancer, Lyme disease, autism, Alzheimer’s disease or COVID-19. However, some wellness centers claim the opposite.
A Meridian wellness center, the Karlfeldt Center, received a warning letter from the Federal Trade Commission in 2021 for “unsubstantiated claims for coronavirus prevention and treatment.”
The letter, sent to owner Michael Karlfeldt, cited advertisements and social media posts from the center or reposted by the center, including one from May 2020 that said, “(hyperbaric oxygen therapy) should be the standard of care for most COVID-19 patients.”
“Hyperbaric Oxygen Treatment for COVID-19 ... IT”S WORKING!...,” the post said. “HBOT is showing excellent results for treating COVID-19!”
Hyperbaric oxygen therapy is being studied for COVID-19, according to the FDA. The agency has not cleared or authorized it to treat the disease.
In response to inquiries from the Statesman, the Karlfeldt Center said it never made such claims.
“The concern that The Karlfeldt Center had claimed that Hyperbaric Oxygen Therapies cures Covid is inaccurate,” the center wrote in an email. “The Federal Trade Commission contacted the Karlfeldt Center in response to a series of Facebook videos by Dr. Karlfeldt discussing nutritional supplements, diet, lifestyle and therapies to support a healthy immune system during the pandemic.”
The FTC’s concern was addressed to the commission’s satisfaction, the center said.
Patients visiting wellness centers are hoping to receive treatment for everything from palsy to traumatic brain injury to autoimmune conditions, Quinn said. Some mild hyperbaric therapy patients are looking for help with difficult, debilitating conditions, he said, and they may be desperate and willing to spend money on treatments that lack sufficient evidence.
“They’re taking advantage of people,” he said. “They’re claiming to treat all kinds of things under the sun that there’s really no data for.”
Many patients that come into Saint Alphonsus’ clinic don’t understand the difference between medical and mild hyperbaric interventions, Quinn said.
“It can be confusing, and because it’s not regulated, the purveyors of that business can say whatever they want and convince people of almost anything,” Quinn said. “I would encourage patients to get the facts.”
Garrett says people searching for mild hyperbaric oxygen therapy fall into a gap where they may not have insurance or access to an accredited program, which are often at hospitals or medical centers. Patients receiving the regulated form of therapy are usually already in the health care system.
“I hate to see people get robbed,” Garrett said. “And I hate to see people become more damaged because they didn’t get proper health care.”
This story was originally published August 18, 2022 at 4:00 AM.
